Burkert's Robolux valves have eliminated deadlegs and reduced the requirement for diaphragm valves from eight to two on sterile filling units used by Astra Zeneca to produce Pulmicort.
Astra Zeneca's production of Pulmicort asthma medication requires ingredients to be mixed together with water to create a final formulation, which is then packaged in plastic ampoules (in a Blow Fill Seal process) as part of a closed-cycle process. However, the active ingredient in the medicine is not soluble, so the mixture is a suspension rather than a solution. To avoid sedimentation it is imperative that the formulation is kept in continuous motion after mixing until it is filled and sealed. Any deadlegs in the system, where sedimentation might potentially occur, have to be minimised to ensure correct product concentrations are maintained. Achieving this goal always proved challenging, but when Astra Zeneca needed to increase production capacity, finding a better solution to this problem became essential.
The problem with dead legs, which were inherent in the original systems, was solved by using Burkert Robolux four-connection, four-seat valves. By arranging the required valves and flow paths in single units above and below the holding tank, deadlegs were eliminated. In addition, the Robolux valve arrangement greatly simplified the design and installation of the new systems; the number of valves was reduced from eight to two, and the number of T-pieces required was reduced too. A further benefit was that the overall cost of installation and validation was lower, and the neater design made future maintenance and cleaning procedures far easier.
After the success of the first installation, two new systems using Robolux valves were quickly added to the facility. The outstanding success of the initial Robolux applications resulted in follow-up applications of the valves when production was increased further at the pharmaceutical plant. Two new installations were commissioned using the valves; one of these in a clean room - a class 100,000 sterile environment - where stringent monitoring ensures product quality.
Commenting on the latest project, a spokesman for Astra Zeneca said: "Compared to conventional valves the Robolux valves give us a far better flow path and process function, shortening cycle times and making sure our filling operation runs smoothly."
About Robolux valves
Robolux valves are supplied with either manual or pneumatic actuators in sizes from 1/4inch to 2inch (DN4 -50). They are manufactured with a choice of body types: 316-L stainless steel, ultra-pure polypropylene, polypropylene USP V1 and PVDF (polyvinyl-difluoride). The valves also offer a wide range of diaphragm materials to suit all types of media, including EPDM, FKM, PFA/EPDM, PTFE, silicone and PFR91.
Robolux valves hold all major certifications: FDA, CE, USP V, USP VI, ATEX, 3.1 and are applicable worldwide. They are used successfully in chromatography, but are also suitable for a wider range of applications including CIP/SIP processes, UF/MF filtration and filling and formulation.
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